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Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection

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ClinicalTrials.gov Identifier: NCT01501708
Recruitment Status : Unknown
Verified May 2016 by Jiong HU, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : December 29, 2011
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Jiong HU, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.

Condition or disease Intervention/treatment Phase
Leukemia Transplantation, Hematopoietic Stem Cell Drug: Caspofugin based combination therapy Phase 2

Detailed Description:
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
Study Start Date : December 2011
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Caspofugin based combination therapy

Caspofugin based combination therapy:

Patients will recieve caspofungin with voriconazole or amphotericin B

 Drug: Caspofugin based combination therapy

Caspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d.

  • All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.
  • In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.
Other Name: caspofungin + voriconazole or amphotericin B


Outcome Measures
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Primary Outcome Measures :
  1. Favorable response rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 weeks, 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patient undergoing allogeneic hematopoietic stem cell transplantation
  • age 18-55 years
  • with inform consent
  • no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
  • HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
  • proven or probable IFI

Exclusion Criteria:

  • age less than 18 years or over 56 years
  • HLA mismatched related donor
  • liver function/renal function damage (over 2 X upper normal range)
  • with mental disease
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501708


Contacts
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Contact: Jiong HU, M.D. 86-21-64370045 ext 601818 hujiong@medmail.com.cn

Locations
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China
Blood & Marrow Transplantation Center, RuiJin Hospital Recruiting
Shanghai, China, 200025
Contact: Ling Wang, M.D    86-21-64370045 ext 601818      
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Ling Wang, M.D. Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
More Information
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Responsible Party: Jiong HU, M.D., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01501708    
Other Study ID Numbers: RJH-2011-71
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jiong HU, Shanghai Jiao Tong University School of Medicine:
caspofungin
IFI
allogeneic hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Mycoses
Invasive Fungal Infections
Infections
Bacterial Infections and Mycoses
Voriconazole
Amphotericin B
Caspofungin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents